Suprascapular Nerve Block Efficacy for Shoulder Surgery

April 27, 2020 updated by: Ivan Simionato

Suprascapular Nerve Block Efficacy for Arthroscopic Rotator Cuff Repair: a Randomized Clinical Trial

This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peripheral nerve blocks are widely used for postsurgical analgesia. Interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade.

The interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. Complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques.

The suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035072
        • Irmandade Santa Casa de Misericordia de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 80 years old
  • Confirmed rotator cuff tear by magnetic resonance imaging

Exclusion Criteria:

  • Irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration)
  • Partial repair of cuff tears (immobile lesions)
  • Rheumatic diseases
  • Neck-related shoulder pain
  • Glenohumeral instability or osteoarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suprascapular nerve block (SSNB)
Single shot using the blind block technique with 10 ml 0.75% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water.
Procedure: Suprascapular nerve block
The patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%.
Procedure: Arthroscopic rotator cuff repair
Conventional arthroscopic rotator cuff repair.
Active Comparator: Interscalene Nerve Block (ISB)
Single shot using US-guided interscalene brachial plexus block with 15 ml 0.5% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water.
Procedure: Arthroscopic rotator cuff repair
Conventional arthroscopic rotator cuff repair.
Procedure: Interscalene Nerve Block
The patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%.
Other Names:
  • Interscalene Brachial Plexus Nerve Blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity: Numeric Pain Rating Scale
Time Frame: 1 hour after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
1 hour after surgery
Pain intensity: Numeric Pain Rating Scale
Time Frame: 24 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
24 hours after surgery
Pain intensity: Numeric Pain Rating Scale
Time Frame: 48 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
48 hours after surgery
Pain intensity: Numeric Pain Rating Scale
Time Frame: 72 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate Consumption
Time Frame: Postoperative hours 1-72
Total amount of narcotics consumed during the postoperative period measured in morphine equivalents (OME).
Postoperative hours 1-72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivan Simionato

Investigators

  • Principal Investigator: Marcelo F Silva, PhD, Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShoulderSurgeryGroupSCPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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